The present invention relates to the field of respiratory therapy and specifically to the field of lung ventilation to treat a variety of pulmonary diseases.
Lung diseases are the number one category of diseases and a leading cause of death worldwide. Some lung diseases, such as Chronic Obstructive Pulmonary Disease (COPD), Acute Respiratory Distress Syndrome (ARDS), Severe Acute Respiratory Syndrome (SARS) and cystic fibrosis (CF) usually require some form of ventilation assistance or delivery of therapeutic agents in order to clinically improve the patient.
COPD in particular effects tens of millions of people and is one of the top five leading causes of death. COPD is a spectrum of problems, including bronchitis and emphysema, and involves airway obstruction, lung elasticity loss and trapping of stagnant CO2-rich air in the lung. Emphysema, the worst form of COPD, occurs when there is a breakdown in the elasticity in the lung changing clusters of individual alveoli into large air pockets, thereby significantly reducing the surface area for gas transfer. In some cases air leaks out of the compromised walls of the minute airways to the periphery of the lung causing the membranous lining to separate and forming large air vesicles called bullae. Also due to elasticity loss, small conducting airways leading to the alveoli become flaccid and have a tendency to collapse during exhalation, trapping large volumes of air in the now enlarged air pockets, thus reducing bulk air flow exchange and causing CO2 retention in the trapped air. Mechanically, because of the large amount of trapped air at the end of exhalation, known as elevated residual volume, the intercostal and diaphragmatic inspiratory muscles are forced into a pre-loaded condition, reducing their leverage at the onset of an inspiratory effort thus increasing work-of-breathing and dyspnea. Also, areas with more advanced emphysema and more trapped air tend to comprise the majority of the chest cavity volume and tend to fill preferentially during inspiration due to their low elasticity, thus causing the healthier portions to be disproportionately compressed rather than inflating normally during inspiration and receiving their share of inspired air. In emphysema therefore more effort is expended to inspire less air and the air that is inspired contributes less to gas exchange.
ARDS is a respiratory insufficiency caused by a variety of underlying problems such as lung injury, infection, edema, or atelectasis. SARS is a sudden respiratory insufficiency and appears to be caused by a viral infection. CF is a genetic condition in which airways secrete copious amounts of mucus and are inflamed.
Conventionally prescribed therapies for COPD and ARDS and sometimes SARS and CF include pharmacological agents (beta-agonists, aerosolized bronchodilators, anti-inflammatories and mucolytics), supplemental long term oxygen therapy (LTOT) delivered nasally or via tracheotomy, BiLevel Continuous Positive Airway Pressure (BiPAP), which lowers work of inspiration by providing a steady stream of pressure, Tracheal Oxygen Gas Insufflation (TGI), described by Christopher, JAMA 1986; 256: 494-7, which reduces CO2 content in the upper airways thus allowing higher O2 concentrations to reach the distal airways, respiratory muscle rehabilitation, pulmonary hygiene, such as lavage and percussion therapy, lung volume reduction surgery (LVRS) and lung transplantation (LX). These therapies all have certain disadvantages and limitations with regard to effectiveness, targeting accuracy, risk or availability. Usually, after progressive decline in lung function despite attempts at therapy, patients become physically incapacitated or sometimes require more invasive mechanical ventilation to survive in which case weaning from ventilator dependency is often times difficult. Conventional invasive ventilation modes include Continuous Mechanical Ventilation (CMV), Synchronized Intermittent Mechanical Ventilation (SIMV), Positive End Expiratory Pressure (PEEP) therapy, and high frequency jet ventilation (HFJV).
Some newer ventilatory methods have been studied in the attempt to improve treatment of COPD and ARDS. One such method described by Fink, J Resp Care Pract April 1999; 71 is ventilation of a lung with gases of low molecular weights and low viscosity, such as helium-oxygen mixtures or nitric oxide, in order to decrease gas flow resistance and lower surface tension in distal airways and alveolar surfaces, thus increasing oxygen transfer across the alveolar surface into the blood. Another new method includes liquid perfluorocarbon ventilation which can displace mucus in distal airways while still conducting oxygen thus improving gas flow. Another method never successfully commercialized is Negative End Expiratory Pressure (NEEP), which helps remove CO2-rich gas during the exhalation cycle. These invasive methods typically ventilate COPD and ARDS patients more effectively then conventional invasive ventilation modes and may improve weaning, but they are significantly limited in efficacy because they can not easily be provided as chronic treatments and are not target specific. Rather they are inherently designed to treat the whole lung from the upper airway and hence do not address the significant problem of hyperinflation and areas of trapped stagnant gas, nor the problem of maldistribution of inspiratory gas volume.
Some additional devices and techniques have been invented with the aim of improving efficacy. U.S. Pat. No. 6,575,944 describes a catheter that is used for medication delivery through an endotracheal tube. That invention is good for pharmacological therapy on a mechanically ventilated patient, however the invention does not address the significant ventilation needs of the diseased lungs such as trapped gas and hyperinflated lungs.
U.S. Pat. No. 6,520,183 describes a catheter used to block on lung and delivery anesthesia to the other lung. That invention and other like it can only be used for one lung ventilation, almost always for surgery. That invention can be used in the unintended use of shunting ventilation to one lung, if the other lung is too diseased, however this usage would have significant limitations in that lobar or segmental sections of lung could not be individually blocked; hence this therapy would not be selective at all.
U.S. Pat. Nos. 6,227,200; 5,791,337; 5,598,840; 5,513,628; 5,460,613; 5,134,996; and 4,850,350 all describe catheters used for intermittently accessing and suctioning the trachea and main stem bronchi during through a tracheal tube during mechanical ventilation. That invention does not address the severe ventilation problems of the diseased lung, such as trapped air, hyperinflation, and poor airflow and perfusion distribution.
U.S. Pat. No. 5,904,648 describes a catheter for blocking airflow to one lung in order to ventilate and deliver anesthesia to the other side while the blocked side is being operated on. Again, that invention does not address improving ventilation and gas exchange.
U.S. Pat. Nos. 5,255,675 and 5,186,167 describe a catheter placed in the trachea through which the trachea is insufflated with oxygen. In clinical practice that invention and others like it have been proven to reduce the amount of CO2 in the lung and thus improve ventilation, however because the therapy described in this invention can inherently only be applied to the upper airways, it does nothing to improve the significant hyperinflation, air trapping and airflow and perfusion maldistribution of diseased lungs, and thus the therapy is severely limited. Indeed this therapy has not been well received clinically because the amount of benefit does not justify the added attention required.
U.S. Pat. No. 5,193,533 describes an invention similar to U.S. Pat. No. 5,255,675 in which high frequency ventilation is administered to the trachea to improve oxygenation. That invention has been proven clinically useful during short term medical procedures because the lung can be effectively mechanically ventilated at lower pressures but it is not useful as a subacute or chronic therapy as it does not reduce the air trapping, hyperinflation, or airflow and blood perfusion maldistribution.
U.S. Pat. Nos. 4,967,743; 4,838,255 and 4,825,859 describe a catheter for suctioning and ravaging the airways. That invention is limited to managing the airway integrity and pulmonary hygiene and is not suited for directly improving the underlying causes of air trapping, hyperventilation, and air flow maldistribution in the lung.
U.S. Patent Application 20020179090 describes an aspiration catheter for removing phlegm from a lung. This invention is only useful in airway management and is not suited for directly improving the underlying causes of air trapping, hyperventilation, and air flow maldistribution in the lung.
U.S. Patent Application 20010035185 describes a nasal-pharyngeal catheter for delivering breathing gases to the pharynx to supplement regular ventilation or breathing. That invention is incrementally more effective than LTOT in that the gases are delivered more effectively but unfortunately the technique can not directly improve the underlying causes of air trapping, hyperventilation, and air flow maldistribution in the lung
It must be emphasized that an effective ventilation treatment should ideally target specific areas of the lung that are most diseased yet all the methods described in the prior art employ ventilation on the entire lung as a whole, rather than on targeted lung areas that are more diseased. Therefore, all known ventilation modes allow trapped CO2 to persist in the worst effected areas of the lung and allow these areas to remain hyperinflated with the CO2-rich air, thus taking up valuable space in the chest cavity and compressing other potentially contributory lung areas. Other inventions or conventional therapies are either to traumatic, too transient, not site-specific, too experimental or not effective. The present invention disclosed herein addresses these shortcomings as will become apparent in the later descriptions.